Colon Polyp
Conditions
Brief summary
The aim of the first-in-human clinical trial is to evaluate the feasibility of performing colonoscopic polypectomy with a novel colonic intraluminal endoscopic support structure (CIESS) in-situ
Interventions
DEVICEColonic Intraluminal Endoscopic Support Structure
During colonoscopy, if a left-sided colonic polyps is identified, the colonic intraluminal endoscopic support structure (CIESS) will be deployed. Routine polypectomy will be performed. CIESS will be retrieved after polypectomy is completed. Colonoscopy will be completed as per normal routine.Other Name:
Sponsors
JurongHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Positive fecal occult blood test * ASA I/II * only patients with left-sided colonic polyp during colonoscopy will be included into the study eventually
Exclusion criteria
* History of malignancy, gastrointestinal tract/ abdominal surgery, diverticular disease, abdominal/ pelvic radiation * Pregnancy patient * cognitively impaired patients * Patients on blood thinners or anticoagulants * ASA III / ASA IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to deploying CIESS in a single attempt | From enrollment to end of treatment at 4 weeks | Primary outcome measure is whether the CIESS can be deployed successfully in a single attempt - this is a measure of the feasibility of deploying the CIESS during colonoscopy. This outcome will be recorded as successfully deployed in a single attempt or unsuccessfully deployed in a single attempt |
Outcome results
None listed